Business Insights
Diagnostic Technologies
Diseases
Point-of-Care Testing
Research & Development
Sign In
About Us
Careers
Videos
Webinars
Press Releases
Whitepapers
Advertising
FDA Submission: Page 2
Abionic nabs IVDR certification for sepsis test
By
LabPulse.com staff writers
The device detects pancreatic stone protein, an early marker for sepsis, allowing for its identification in about five minutes, Abionic said.
August 8, 2022
I-calQ receives 9th patent for smartphone POC testing
By
LabPulse.com staff writers
I-calQ's technology uses the smartphone as a processor. Its camera is used to read a disposable test strip cassette, and a proprietary app that analyzes, calibrates, and quantifies results in about 10 minutes. It also has the ability to upload the data immediately.
January 14, 2021
MDIC releases IVD regulatory decision-making framework
By
LabPulse.com staff writers
The framework is designed to help the IVD industry and the U.S. Food and Drug Administration (FDA) better incorporate real-world data into development and regulatory decisions for IVD products. It also outlines the designs and statistical methods needed in order to generate real-world evidence for regulatory submissions.
August 23, 2020
HHS: FDA review not needed for coronavirus LDTs
By
Brian Casey
In the guidance, the HHS said that the FDA will not require labs to go through premarket review of LDTs for COVID-19 before they can be used on patients. Labs can choose to seek emergency use authorization (EUA) from the FDA if they wish, and the agency will adjudicate these submissions.
August 19, 2020
Abbott unveils lab-based COVID-19 antibody blood test
By
LabPulse.com staff writers
The IgG antibody test will be available initially on Abbott's Architect i1000SR and i2000SR laboratory instruments, which can run up to 100-200 tests per hour, according to the vendor. The firm is also working to add the test to its new Alinity i platform.
April 15, 2020
Myriad files companion BRCA test in prostate cancer
By
LabPulse.com staff writers
The test detects and classifies variants of BRCA1 and BRCA2 genes in whole blood specimens. An application for Lynparza, which is a poly (ADP-ribose) polymerase inhibitor marketed by AstraZeneca and Merck, in the second-line treatment of metastatic castration-resistant prostate cancer (mCRPC) with suspected deleterious germline or somatic gene mutations has been accepted by the FDA. The filing has priority review with the agency, and a user fee date has been set for the second quarter.
January 20, 2020
FDA moves to electronic-only device submissions
By
LabPulse.com staff writers
The rule, which aims to improve the agency's efficiency, was issued on December 13. The administration plans to publish a revised "eCopy Program for Medical Device Submissions: Guidance for Industry and Food and Drug Administration Staff," which will reflect the amendments to the regulations.
December 12, 2019
FDA airs 'to do' list for devices in 2020
By
LabPulse.com staff writers
The agency's Center for Devices and Radiological Health (CDRH) released its list of planned new guidance documents, with some prioritized for next year, along with a request for input on whether certain older guidance documents should be changed or withdrawn.
October 13, 2019
ACLA blasts FDA's 'troubling actions' on pharmacogenetic tests
By
Emily Hayes
ACLA President Julie Khani spelled out the association's concerns and requested a meeting in a September 18 letter to FDA Acting Commissioner Dr. Ned Sharpless; Dr. Jeffrey Shuren, director of the Center for Devices and Radiological Health; and Dr. Timothy Stenzel, PhD, director of the Office of In Vitro Diagnostics and Radiological Health.
September 18, 2019
SpeeDx Mgen STI test debuts in Europe
By
LabPulse.com staff writers
The diagnostic test screens for Mgen as well as for resistance to the macrolide class of antibiotics, such as azithromycin, which is a first-line treatment for the infection. Cepheid will be responsible for marketing and distributing the Mgen test for use with its Flexible cartridge and GeneXpert system.
September 5, 2019
Prescient Medicine buys AutoGenomics for Infiniti test
By
LabPulse.com staff writers
Prescient said the acquisition will enable the company to advance the development and commercialization of AutoGenomics' Infiniti neural response panel, a diagnostic test for the identification of individuals who may be at risk for opioid use disorder. The acquisition builds on a collaboration between the firms that began in 2017.
April 23, 2019
FDA gives nod to Hologic assay for STI bacterium
By
LabPulse.com staff writers
Called Aptima, it is the first test to be cleared by the FDA for M. genitalium, which is associated with inflammation of the urethra (nongonococcal urethritis) in men and inflammation of the cervix (cervicitis) and infection of the reproductive organs (pelvic inflammatory disease) in women.
January 28, 2019
Previous Page
Page 2 of 2